Partnership for Research on Ebola VACcinations

Summary

The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults. Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA) boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.

Conditions

• Ebola Virus Disease

Interventions

BIOLOGICAL

Ad26.ZEBOV

0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children

BIOLOGICAL

MVA-BN-Filo

0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children

BIOLOGICAL

rVSVΔG-ZEBOV-GP

1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children

BIOLOGICAL

Placebo

0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children

BIOLOGICAL

rVSV boost

1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children

Sponsors & Collaborators

• Partnership for Research on Ebola Virus in Liberia (PREVAIL)

  collaborator NETWORK

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Bailah Leigh · University of Sierra Leone

• Stephen B. Kennedy · Redemption Hospital

• Yazdan Yazdanpannah · Institut National de la Santé Et de la Recherche Médicale, France

• Abdoul Habib Beavogui · Centre de Formation et de Recherche en Santé Rurale de Mafèrinyah

• Mark Kieh · Redemption Hospital

• Seydou Doumbia · Universite des Sciences, des Techniques et des Technologies de Bamako

• Samba O. Sow · Centre pour le Developpement des Vaccins

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-03-27

Primary Completion

2019-12-24

Completion

2023-12-20

FDA Drug

Yes

Countries

• Guinea
• Liberia
• Mali
• Sierra Leone

Study Locations